FDA.report

510(k) K894446

Device
ANGEION HEMOSTASIS VALVE INTRODUCER
Applicant
ANGEION CORP.
510(k) number
K894446
Product code
DYB  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-30
Date received
1989-07-17
Regulation
870.1340
Classification name
Introducer, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
GREGORY G BRUCKER
Address
13000 Hwy. 55 Plymouth MN US 55441 55441

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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